職位描述
職位描述：
崗位職責(zé):
? Building and leading the Biostatistics and Data Management function
? Strategic planning, including development and implementation of clinical development plan
? Preparation of statistical analysis plans
? Application of statistical methods and analysis of clinical study data
? Active participation in randomization development and validation process
? Preparation of statistical section of clinical trial reports
? Review of protocols/case report forms/statistical analysis plans/clinical trial reports
? Interact and manage KOLs/CROs and represent the company in external scientific forums including communication with worldwide regulatory agencies
? Identify, evaluate and implement as needed innovative statistical methods to provide added value to the company drug development process
? Represent the company in partnership (co-development) projects
? Represent the company in interfaces with regulatory agencies globally
? Participate in due diligence for in-license and out-license opportunities
任職資格:
? Ph.D. in Statistics/Biostatistics with at least 7 years of experience in the pharmaceutical industry
? Experience designing Phase (I) II/III clinical trials, oncology trial design experience a plus
? Experience designing and implementing several dynamic randomization plans
? Experience with application of a variety of statistical methods and ability to work on complex statistical problems
? Experience forming DSMB, organizing DSMB board meetings, providing data and communicating with DSMB members
? Solid knowledge of SAS and familiarity with other statistical software packages
? Have thorough understanding of regulatory guidance and statistical methodology as applied to pharmaceutical development
